CSV Validation Engineer

📋 Description

• Lead risk-based CSV validation across cloud apps, edge devices, APIs, and integrations.
• Develop and maintain validation documentation and evidence for inspections.
• Collaborate with Engineering, Product, Quality, Operations, and suppliers.
• Ensure regulatory alignment with 21 CFR Part 11, GMP Annexes, and ALCOA+.
• Translate requirements into testable acceptance criteria and traceability.
• Remain delivery-focused in a remote, growing organization.

🎯 Requirements

• 10+ years in computerized system validation in GxP environments.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+.
• Experience applying risk-based validation and Computer Software Assurance.
• Hands-on with URs, risk assessments, validation plans, protocols, and IQ/OQ/PQ.
• Experience validating configurable software, SaaS, cloud and lab/manufacturing systems.
• Familiarity with REST APIs, SQL, data mappings, and multi-vendor data formats.

🎁 Benefits

• Senior-level ownership across validation and regulated tech platforms.
• Exposure to cloud, edge, lab, manufacturing, API, and instruments.
• Opportunity to strengthen validation practices in a growing org.
• Remote-friendly with autonomy and responsibility.
• Apply modern risk-based validation and Computer Software Assurance.
• Professional growth with evolving tech and regulatory use cases.